Polaris™ Ultra M0061921430Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729124566), received between Nov 28, 2018 and Sep 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that a Polaris Ultra Ureteral stent was used in a Retrograde Intrarenal Surgery (RIRS) procedure in the ureter. During procedure and inside the patient, when attempted to cut the suture, the tip at the end broke. The procedure was completed with another of the same device and there were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870663 ↗
• MalfunctionSep 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER. DURING PREPARATION, A RED SPOT WAS FOUND ON THE BLADDER SIDE OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22980049 ↗
• MalfunctionJun 12, 2024Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT THE STENT DID NOT THREAD WITH THE WIRE. IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT AND NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A STENT BUCKLED MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522775 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A PLANNED PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND BROKEN INTO TWO PIECES ALONG THE SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE DISTAL END OF THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017232 ↗
• MalfunctionJul 6, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETERAL CATHETERIZATION VIA CYSTOSCOPE PROCEDURE IN THE BLADDER, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN UNPACKED THE PACKAGE, IT WAS FOUND THAT THE POLARIS ULTRA URETERAL STENT WAS FRACTURED. ANOTHER POLARIS ULTRA STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233466 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS TO BE USED FOR A URETEROSCOPY (URS) PROCEDURE, TO BE PERFORMED IN THE URETER, ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE STENT BROKE IN HALF ALONG THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274690 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS UNPACKED FOR USE FOR A URETERAL STENTING PROCEDURE TO BE PERFORMED IN THE LEFT URETER ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE SUTURE WAS REMOVED AND THE STENT WAS NOTICED TO BE DAMAGED. IT WAS REPORTED THAT THE STENT WAS DAMAGED BY SCISSORS WHEN ATTEMPTING TO REMOVE THE SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8113331 ↗